Director, Biostatistics

Role Description

As Director, Biostatistics, this role will provide statistical support for clinical development of Definium’s pipeline compounds, regulatory filing, and commercialization effort. Reporting to Vice President, Head of Biometrics and Data Science, this role will serve as the lead biostatistician for the assigned clinical programs and/or clinical studies, providing statistical leadership from clinical trial design, data analysis - covering planning and execution - to results interpretation and dissemination. This role will be hands-on while offering statistical and strategic input to all clinical activities where statistical input can make a difference or is requested. A key responsibility of this role will be ensuring that the deliverables from our statistical vendors are of high quality and meet deadlines, in close collaboration with the Definium Statistical Programming group and multi-functional teams. Additionally, the role will perform statistical analyses using own SAS programs as needed, and support data cleaning activities in collaboration with the Clinical Data Management group and other functions within Clinical Development organization.

• Provide statistical input to the creation of clinical development plan for the assigned compound(s)
• Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objective, endpoints and sample size
• Play as an integral part of a protocol development team by authoring statistical methods section and reviewing the protocol throughout
• Ensure the accuracy of randomization algorithm and contribute to eCRF design to ensure data collection’s alignment with study objectives
• Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
• Hold the primary responsibility of working with statistical vendors to implement the SAP and deliver study results with quality and speed
• Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
• Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
• Conduct data analyses as needed by using own SAS programs in collaboration with Statistical Program group for validation
• Contribute to the development of Biometrics’ SOPs

Qualifications

• A PhD degree in Statistics or Biostatistics with at least 10 years’ working experience in pharmaceutical or biotechnology companies
• Solid statistical knowledge and experience in clinical trial design from early to late phase, data analysis and reporting
• Strong track record using statistical methods to solve real problems emerged in clinical trials and resulted in right decision-making and/or compound advancement
• Rich experience in authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions of high quality
• Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed
• Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis
• Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
• Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals
• Strong organizational and project management skills; demonstrated interests of continued learning and growing
• Detail-oriented and hold high standards of excellence for own work products
• Deliver and communicate effectively in the work-from-home environment
• Excellent interpersonal skills and is a good team player

Requirements

• The starting base pay range for this position is $224,643.00 - $249,312.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
• Employees in this role may be entitled to additional compensation, including bonus and equity.

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!